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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K192547
Device Name MAGLUMI 2000 HCG/ß-HCG
Applicant
Shenzhen New Industries Biomedical Engineering Co., Ltd.
#16, Jinhui Rd., Pingshan New District
Shenzhen,  CN 518122
Applicant Contact Jie Rao
Correspondent
LSI International, Inc.
504 E. Diamond Ave., Suite F
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.1155
Classification Product Code
DHA  
Date Received09/17/2019
Decision Date 01/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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